Hologic Gets FDA Approval for New Low-Dose Breast Tomosynthesis Solution

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Hologic has announced US Food and Drug Administration approval of its new C-View 2D imaging software. C-View 2D images may now be used in place of the conventional 2D exposure previously required as part of a Hologic 3D mammography (breast tomosynthesis) screening exam.

C-View images are generated from the 3D tomosynthesis data acquired during the mammography exam, eliminating the need for additional 2D exposures. The combination of Hologic's 3D and C-View 2D images results in less time under compression, for greater patient comfort and a lower radiation dose, while still providing the 2D images required as part of Hologic's FDA approved 3D mammography screening exam. Clinical studies have shown that screening with Hologic's 3D mammography technology using C-View imaging results in clinical performance superior to that of a conventional 2D mammogram.

Peter Soltani, Hologic Senior Vice President and General Manager, Breast Health, said: "C-View software was developed to provide yet another option to imaging centres to improve patient care and clinical outcomes. Large-scale clinical studies have shown that screening with Hologic's 3D mammography technology allows radiologists to visualise the breast in greater detail than with 2D mammography alone, which results in earlier detection of cancers while at the same time reducing the false positives associated with conventional 2D mammography that cause unnecessary anxiety and cost."

Hologic's 3D mammography technology has been approved for use in countries recognising the CE mark since 2008. It was approved for use in the U.S. for breast cancer screening and diagnosis in 2011. Hologic systems are now in use in 48 states in the U.S. and over 50 countries. C-View 2D imaging software has been commercially available in Europe and many countries in Latin America and Asia since 2011. C-View software is available as an optional package to new and existing customers. Hologic expects to begin shipments in the U.S. in June 2013.

Image credit: Hologic The images above show a cancer (invasive ductal carcinoma)

Published on : Fri, 24 May 2013


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Tomosynthesis, Mammography, Hologic Hologic has announced US Food and Drug Administration approval of its new C-View 2D imaging software. C-View 2D images may now be used in place of the conv

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